North Macedonia – Medical equipments, pharmaceuticals and personal care products – Integrated systemic perfusion system designed for an extracorporeal circulation machine.

Description

Sterile Perfusion System Venous Line For the drainage of blood from the patient, through the venous cannula, to the cardiotomy reservoir, a venous line made of PVC tubing with an internal diameter of 1/2 inch shall be provided. Measured from the oxygenator, the initial segment shall be 45 cm long (±5%). It shall be followed by a connector with a shunt to the arterial line, and then by tubing 240 cm long (±5%), which connects to the terminal end of the arterial line. The venous line shall not be equipped with a saturation sensor. Arterial Line The return of oxygenated blood from the oxygenator to the patient, through the arterial cannula, shall be performed via an arterial line made of PVC tubing with an internal diameter of 3/8 inch. Starting from the oxygenator, the first segment shall be 55 cm long (±5%), followed by a connector with a shunt to the venous line. After the connector, the tubing shall continue for 200 cm (±5%) and shall be connected to the terminal end of the venous line via a 3/8 × 1/2 inch connector. Arteriovenous Shunt The shunt between the arterial and venous lines shall have an internal diameter of 1/4 inch and shall be equipped with a Robertson clamp. Line Holder An independent line holder, not attached to the tubing, shall be included, with a capacity for at least five lines. The holder shall allow positioning of the arterial and venous lines, suction line, vent line and external suction line within the surgical field. Suction Line The suction line shall be colour-coded and shall have the following configuration: Initial segment made of PVC tubing with an internal diameter of 1/4 inch and a length of 100 cm. 1/4 × 3/8 inch connector for connection to silicone tubing with an internal diameter of 3/8 inch and a length of 60 cm. 3/8 × 1/4 inch connector with a Luer-lock fitting, followed by PVC tubing with an internal diameter of 1/4 inch and a length of 270 cm, extending to the operating table. A tolerance of ±5% shall be permitted for the specified lengths. Suction Line – Vent The vent suction line shall be colour-coded and shall consist of: PVC tubing with an internal diameter of 1/4 inch and a length of 100 cm. 1/4 × 3/8 inch connector connected to silicone tubing with an internal diameter of 3/8 inch and a length of 60 cm. 3/8 × 1/4 inch connector with a Luer-lock fitting, followed by PVC tubing with an internal diameter of 1/4 inch and a length of 210 cm, extending to the operating table. A one-way valve shall be incorporated into the line, oriented to allow flow from the patient towards the extracorporeal circulation machine. The permitted tolerance for the specified lengths shall be ±5%. External Suction Line A colour-coded external suction line, 5 m long (±5%), shall be provided, with a terminal 1/4 × 1/4 inch connector. Each of the three suction lines shall be identified by a different colour. Gas Blender Connection The system shall include a connection for the gas blender, equipped with a filter. Main Roller Pump Tubing Segment The main roller pump line shall have the following sequential configuration: PVC tubing with an internal diameter of 3/8 inch and a length of 60 cm. 3/8 × 1/2 inch connector. Silicone tubing with an internal diameter of 1/2 inch and a length of 60 cm. 1/2 × 3/8 inch connector. Final segment of PVC tubing with an internal diameter of 3/8 inch and a length of 60 cm. One of the connectors shall be equipped with a Luer-lock port for measuring pre-membrane pressure. A tolerance of ±5% shall be permitted for each specified length. Priming Line The line for priming the extracorporeal circulation machine shall be 130 cm long (±5%) and shall include three spike adapters. Extension Line with One-Way Valve and Pressure Transducer Protector An extension line shall be included, consisting of an initial segment 20 cm long, followed by a one-way valve. After the valve, the line shall continue for 80 cm up to a three-way stopcock. A pressure monitoring line, 80 cm long and equipped with a pressure transducer protector, shall extend from the three-way stopcock. A tolerance of ±5% shall be permitted for all specified lengths. Additional Pressure Monitoring Line An additional pressure monitoring line, 80 cm long (±5%), equipped with a pressure transducer protector, shall be provided. Blood Transfer Bag The system shall include a sterile blood transfer bag with a capacity of at least 2,000 ml. Additional Connectors The system shall include: One straight male-to-female one-way double connector. Three three-way stopcocks. Reservoir Level Sensor Each sterile adult perfusion set shall be supplied with an adhesive patch and a sensor for monitoring the blood volume level in the reservoir (Level Sensor). Oxygenator The oxygenator shall meet the following requirements: Flow rate: 5 to 8 L/min. Integrated arterial filter. Priming volume: maximum 450 ml. Reservoir capacity: 4,000 to 4,500 ml. Two cardioplegia connectors. Blood Cardioplegia Set Inlet Lines and Connections The initial section of the set shall consist of two PVC lines with dimensions of 1/4 × 1/16 × 20 cm, each equipped with a spike at the proximal end. The two lines shall be joined via a Y-connector. A PVC line with dimensions of 1/4 × 1/16 × 90 cm shall extend from the Y-connector and shall be connected, via a 1/4 × 1/4 inch connector, to silicone tubing with dimensions of 1/4 × 1/16 × 40 cm. The silicone tubing shall be connected to one branch of the next Y-connector. Another line shall be connected to the same Y-connector, consisting of a PVC segment with dimensions of 1/4 × 1/16 × 100 cm, a 1/4 × 1/4 inch connector, and a silicone segment with dimensions of 1/4 × 1/16 × 40 cm. Line to the Heat Exchanger A PVC line with dimensions of 1/4 × 1/16 × 10 cm shall extend from the common Y-connector. It shall be followed by a 1/4 × 1/4 inch connector with a male cap, and then by a PVC line with dimensions of 1/4 × 1/16 × 50 cm, which shall be connected

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